Clinical Trial: Chemoradiotherapy and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma

This study is currently recruiting patients.

Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
National Cancer Institute of Canada
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and radiation and kill more cancer cells. It is not yet known whether chemoradiotherapy plus peripheral stem cell transplantation is more effective than combination chemotherapy alone in treating non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying chemoradiotherapy and peripheral stem cell transplantation to see how well they work compared to combination chemotherapy in treating patients with stage II, stage III, or stage IV non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
adult Burkitt's lymphoma
adult diffuse large cell lymphoma
adult diffuse mixed cell lymphoma
adult diffuse small cleaved cell lymphoma
adult immunoblastic large cell lymphoma
grade 3 follicular lymphoma
 Drug: carmustine
 Drug: cyclophosphamide
 Drug: doxorubicin
 Drug: etoposide
 Drug: filgrastim
 Drug: prednisone
 Drug: rituximab
 Drug: sargramostim
 Drug: vincristine
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: high-dose chemotherapy
 Procedure: monoclonal antibody therapy
 Procedure: peripheral blood stem cell transplantation
 Procedure: radiation therapy
Phase III

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphatic Diseases;   Lymphoma;   Viral Infections

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Study of Early High-Dose Chemoradiotherapy and Autologous Peripheral Blood Stem Cell Transplantation Versus Conventional Dose Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients with Intermediate- or High-Grade Non-Hodgkin's Lymphoma

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a randomized study. Patients are stratified according to disease risk (intermediate-high vs high).

Patients receive CHOP chemotherapy comprising cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Patients with CD20-positive disease also receive rituximab IV on day 1 (or day 0 during course 1 only). Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

Within 35 days of completing the fifth course, patients with partial or complete response are randomized to one of two treatment arms.

  • Arm I: Patients receive CHOP (or CHOP plus rituximab [CHOP-R]) as above. Treatment repeats every 3 weeks for 3 additional courses. After completion of chemotherapy, patients are encouraged to undergo harvest of peripheral blood stem cells (PBSC) for possible use at time of relapse. After completion of 8 courses, patients receive no additional therapy until disease progression or biopsy-proven disease.
  • Arm II: Patients receive one additional course of CHOP/CHOP-R followed by filgrastim (G-CSF), sargramostim (GM-CSF), or other colony-stimulating factors used singly or in combination according to center preference. PBSC are harvested and selected for CD34+ cells. Patients under age 61 receive one of two preparative regimens: a total body irradiation (TBI)-based regimen comprising irradiation administered twice daily on days -8 to -5, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 1 hour on day -2 OR carmustine IV over 2 hours on days -6 to -4 and etoposide and cyclophosphamide as in the TBI-based regimen. Patients age 61 to 65 receive the augmented regimen comprising carmustine, etoposide, and cyclophosphamide as above. Patients receive involved field radiotherapy prior to the preparative regimen only if there is biopsy-proven residual bulk disease and at the discretion of the center. PBSC are reinfused 36-48 hours after completion of cyclophosphamide. If both bone marrow and PBSC are harvested, bone marrow is reinfused on day 0 and then PBSC are reinfused either the same day or the following day. Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: Approximately 360 patients (at least 135 per treatment arm) will be accrued for this study within 5 years.

Eligibility

Ages Eligible for Study:  15 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven intermediate- or high-grade non-Hodgkin's lymphoma
  • Ann Arbor classification of "bulky" stage II, III, or IV
  • Must be classified as high-intermediate or high-risk according to International Age Adjusted Index
  • Bidimensionally measurable disease
  • No lymphoblastic, transformed, or mantle cell lymphomas
  • No CNS involvement by lymphoma
  • CD20 status confirmed by immunocytochemistry or flow cytometry
  • Must have either bilateral or unilateral bone marrow aspiration and biopsy ≥ 42 days before first course of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy (or CHOP plus rituximab [CHOP-R] for CD20+ disease) OR within 42 days prior to registration if CHOP/CHOP-R therapy has not begun
  • Must have bilateral bone marrow aspiration and biopsy within 28 days of randomization
  • Bone marrow involvement with lymphoma is allowed, provided there is an improvement of at least 50% if used as an evaluable site of disease
  • No prior lymphoma, Hodgkin's lymphoma, myelodysplastic syndromes, or leukemia NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age:

  • 15 to 65

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • No nonlymphoma-related hepatic dysfunction

Renal:

  • Creatinine no greater than 2 times ULN
  • Creatinine clearance at least 60 mL/min
  • No nonlymphoma-related renal dysfunction
  • No history of grade 3 hemorrhagic cystitis due to cyclophosphamide

Cardiovascular:

  • No coronary artery disease, cardiomyopathy, congestive heart failure, or dysrhythmia requiring therapy
  • MUGA scan or 2-D echocardiogram required if patient's history is questionable
  • Ejection fraction normal

Pulmonary:

  • DLCO or FEV_1 at least 60% of predicted

Other:

PRIOR CONCURRENT THERAPY: Biologic therapy:

Chemotherapy:

Endocrine therapy:

  • See Chemotherapy
  • Prior corticosteroids allowed

Radiotherapy:

Surgery:

  • Not specified

Location and Contact Information


Alabama
      MBCCOP - Gulf Coast, Mobile,  Alabama,  36607,  United States; Recruiting
Paul O. Schwarzenberger, MD  251-544-1013 

      Northeast Alabama Regional Medical Center, Anniston,  Alabama,  36207,  United States; Recruiting
Thomas W. Twele, MD  256-236-2549 

      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States; Recruiting
Carla I. Falkson, MD  205-975-2691    cfalkson@uab.edu 

Arizona
      Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson,  Arizona,  85724,  United States; Recruiting
Thomas P. Miller, MD  520-626-2667 

      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States; Recruiting
Tom Robert Fitch, MD  480-301-9875 

      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
David Kyle King, MD, FACP  602-239-2413    david.king@baannerhealth.com 

      Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix,  Arizona,  85012,  United States; Recruiting
Thomas Dale Kummet, MD  602-277-5551 

      Veterans Affairs Medical Center - Tucson, Tucson,  Arizona,  85723,  United States; Recruiting
Harinder S. Garewal, MD  520-629-4686 

Arkansas
      Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States; Recruiting
Laura Fulper Hutchins, MD  501-686-8511    LFHutchins@uams.edu 

      Veterans Affairs Medical Center - Little Rock, Little Rock,  Arkansas,  72205,  United States; Recruiting
Bart Barlogie, MD  501-526-2873 

California
      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States; Recruiting
Joseph Szumowski, MD  510-465-8570 

      CCOP - Santa Rosa Memorial Hospital, Santa Rosa,  California,  95403,  United States; Recruiting
Ian C. Anderson, MD  707-521-3830 

      Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange,  California,  92868,  United States; Recruiting
Randall F. Holcombe, MD  714-456-5153    rholcomb@uci.edu 

      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States; Recruiting
Clinical Trials Office - New Patient Services  800-826-4673    becomingapatient@coh.org 

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States; Recruiting
John L. Barstis, MD  310-825-5268 

      Naval Medical Center - San Diego, San Diego,  California,  92134-3202,  United States; Recruiting
Preston Gable, MD  619-532-7303    pgable@nmcsd.med.navy.mil 

      Rebecca and John Moores UCSD Cancer Center, La Jolla,  California,  92093-0658,  United States; Recruiting
Stephen L. Seagren, MD  619-543-5303 

      University of California Davis Cancer Center, Sacramento,  California,  95817,  United States; Recruiting
David R. Gandara, MD  916-734-3772    dgandara@cc.ucdmc.ucdavis.edu 

      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033,  United States; Recruiting
Heinz-Josef Lenz, MD  323-865-3955    lenz@usc.edu 

      Veterans Affairs Medical Center - Loma Linda (Pettis), Loma Linda,  California,  92357,  United States; Recruiting
Mark E. Reeves, MD, PhD  909-583-6064 

      Veterans Affairs Medical Center - San Diego, San Diego,  California,  92161,  United States; Recruiting
Saeeda Kirmani, MD  619-552-8585 ext. 3356    skirmani@ucsd.edu 

      Veterans Affairs Medical Center - San Francisco, San Francisco,  California,  94121,  United States; Recruiting
Patricia A. Cornett, MD  415-221-4810 ext. 3423    patricia.cornett@med.va.gov 

      Veterans Affairs Outpatient Clinic - Martinez, Martinez,  California,  94553,  United States; Recruiting
David R. Gandara, MD  925-372-2064 

Colorado
      Boulder Community Hospital, Boulder,  Colorado,  80301-9019,  United States; Recruiting
John Thomas Fleagle, MD  303-440-2399 

      CCOP - Colorado Cancer Research Program, Incorporated, Denver,  Colorado,  80224,  United States; Recruiting
Eduardo R. Pajon, MD  303-777-2663    erpajon@aol.com 

      Hope Cancer Care Center at Longmont United Hospital, Longmont,  Colorado,  80501,  United States; Recruiting
Robert Evan Fisher, MD  303-485-4132 

      Medical Center of Aurora - South Campus, Aurora,  Colorado,  80012-0000,  United States; Recruiting
Sami G. Diab, MD  303-418-7600 

      Penrose Cancer Center at Penrose Hospital, Colorado Springs,  Colorado,  80933,  United States; Recruiting
Robert Lynn Sayre, MD  719-577-2555 

      Porter Adventist Hospital, Denver,  Colorado,  80210,  United States; Recruiting
David Trevarthen, MD  303-788-8675 

      Presbyterian - St. Luke's Medical Center, Denver,  Colorado,  80218,  United States; Recruiting
Robert M. Jotte, MD, PhD  303-388-4876 

      Rocky Mountain Cancer Centers - Denver Rose, Denver,  Colorado,  80220,  United States; Recruiting
Scot M. Sedlacek, MD  303-321-0302 

      Rocky Mountain Cancer Centers - Thornton, Thornton,  Colorado,  80229,  United States; Recruiting
Alvin L. Otsuka, MD  303-386-7622    aotsuka@direcpc.com 

      Sky Ridge Medical Center, Lone Tree,  Colorado,  80124,  United States; Recruiting
Dennis Carter, MD  720-225-4200 

      St. Joseph Hospital, Denver,  Colorado,  80218-1191,  United States; Recruiting
Michael McLaughlin, MD  303-861-3302 

      St. Mary-Corwin Regional Medical Center, Pueblo,  Colorado,  81004,  United States; Recruiting
Marlow M. Sloan, MD  719-560-6000 

      Swedish Medical Center, Englewood,  Colorado,  80112,  United States; Recruiting
Marshall Davis, MD  303-788-5860 

      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora,  Colorado,  80010,  United States; Recruiting
Anthony D. Elias, MD  720-848-1622    Anthony.Elias@uchsc.edu 

      Veterans Affairs Medical Center - Denver, Denver,  Colorado,  80220,  United States; Recruiting
Madeleine A. Kane, MD, PhD  303-399-8020 ext. 3129    madeleine.kane@med.va.gov 

Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States; Recruiting
Stephen Scott Grubbs, MD  302-623-4100 

District of Columbia
      Lombardi Cancer Center at Georgetown University Medical Center, Washington,  District of Columbia,  20007,  United States; Recruiting
Edward P. Gelmann, MD  202-444-7303    gelmanne@georgetown.edu 

      MBCCOP - Howard University Cancer Center, Washington,  District of Columbia,  20060,  United States; Recruiting
Lucile L. Adams-Campbell, PhD  202-806-7697 

      Veterans Affairs Medical Center - Washington, DC, Washington,  District of Columbia,  20422,  United States; Recruiting
Steven H. Krasnow, MD  202-745-8178    krasnow.steven@washington.va.gov 

      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5001,  United States; Recruiting
Thomas Joseph Reid, MD, PhD, FACP  202-782-5762    thomas.reid@na.amedd.army.mil 

Florida
      Broward General Medical Center, Fort Lauderdale,  Florida,  33316,  United States; Recruiting
Luis Ramon Barreras, MD, FACP  954-771-0692 

      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States; Recruiting
Rogerio C. Lilenbaum, MD  305-674-2625 

      Florida Hospital Cancer Institute, Orlando,  Florida,  32804,  United States; Recruiting
Jane Crofton, RN, BSN, OCN  407-303-2090 

      Memorial Cancer Institute at Memorial Regional Hospital, Hollywood,  Florida,  33021,  United States; Recruiting
Atif M. Hussein, MD  954-986-6363 

      Palm Beach Cancer Institute - West Palm Beach, West Palm Beach,  Florida,  33401,  United States; Recruiting
Robert J. Jacobson, MB, ChB, FACP, FRCP(C)  561-366-4150 

      Veterans Affairs Medical Center - Tampa (Haley), Tampa,  Florida,  33612,  United States; Recruiting
Raoul R. Salup, MD  813-972-7579    raoul.salup@med.va.gov 

Georgia
      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States; Recruiting
Thomas E. Seay, MD, PhD  404-851-2340 

Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
Brian F. Issell, MD  808-586-3015    brian@crch.hawaii.edu 

Illinois
      Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood,  Illinois,  60153-5500,  United States; Recruiting
Patrick J. Stiff, MD  708-327-3148 

      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States; Recruiting
James L. Wade, MD  217-876-6617    jlwade3@sbcglobal.net 

      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
Gershon Y. Locker, MD, FACP  847-570-2518    glocker@enh.org 

      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61615-7828,  United States; Recruiting
John W. Kugler, MD  309-243-3605 

      Louis A. Weiss Memorial Hospital, Chicago,  Illinois,  60640,  United States; Recruiting
Keith L. Shulman, MD  773-564-5022    KShulman@weisshospital.org 

      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States; Recruiting
Lawrence Eric Feldman, MD  312-335-3614 

      Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago,  Illinois,  60611,  United States; Recruiting
Al Bowen Benson, MD, FACP  312-695-1382 

      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States; Recruiting
Karen Wendling  773-834-7424 

      Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago,  Illinois,  60612,  United States; Recruiting
Lawrence Eric Feldman, MD  312-569-6129 

      Veterans Affairs Medical Center - Hines, Hines,  Illinois,  60141,  United States; Recruiting
Nirmala Bhoopalam, MD  708-202-2782 

      West Suburban Center for Cancer Care, River Forest,  Illinois,  60305,  United States; Recruiting
John L. Showel, MD  708-763-2700    doc.shoj@wsmc.org 

Indiana
      Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne,  Indiana,  46885-5099,  United States; Recruiting
Sreenivasa Rao Nattam, MD  260-484-8830    ledgar@fwmoh.com 

Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1009,  United States; Recruiting
Gerald H. Clamon, MD  319-356-8110 

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
Shaker R. Dakhil, MD, FACP  316-268-5784 

      Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City,  Kansas,  66160-7353,  United States; Recruiting
Sarah A. Taylor, MD  913-588-6029    sataylor@kumc.edu 

      Veterans Affairs Medical Center - Wichita, Wichita,  Kansas,  67218,  United States; Recruiting
Shaker R. Dakhil, MD, FACP  316-685-2221 

Kentucky
      Baptist Hospital East - Louisville, Louisville,  Kentucky,  40207,  United States; Recruiting
Daniel C. Scullin, MD  502-897-1166 

      Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536-0084,  United States; Recruiting
Michael A. Doukas, MD  859-257-3379 

      Veterans Affairs Medical Center - Lexington, Lexington,  Kentucky,  40502-2236,  United States; Recruiting
Michael A. Doukas, MD  859-281-4956 

Louisiana
      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States; Recruiting
Glenn M. Mills, MD  318-675-5970    gmills@lsuhsc.edu 

      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
Jill Gilbert, MD  504-568-5613    jgilbe@lsuhsc.edu 

      Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans,  Louisiana,  70112,  United States; Recruiting
Alan M. Miller, MD, PhD  504-587-7566    amiller@tulane.edu 

      Veterans Affairs Medical Center - New Orleans, New Orleans,  Louisiana,  70112,  United States; Recruiting
German S. Beltran, MD  504-588-5482 

      Veterans Affairs Medical Center - Shreveport, Shreveport,  Louisiana,  71101-4295,  United States; Recruiting
Glenn M. Mills, MD  318-221-8411 

Maryland
      Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore,  Maryland,  21201,  United States; Recruiting
Martin J. Edelman, MD  410-328-2703    medelman@umm.edu 

Massachusetts
      Cancer Center at Tufts - New England Medical Center, Boston,  Massachusetts,  02111,  United States; Recruiting
John K. Erban, MD  617-636-5147    jerban@tufts-nemc.org 

      Cancer Research Center at Boston Medical Center, Boston,  Massachusetts,  02118,  United States; Recruiting
Evan Vosburgh, MD  617-638-8265    evan.vosburgh.b@bayer.com 

      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
George P. Canellos, MD  617-632-3470    george_canellos@dfci.harvard.edu 

      UMASS Memorial Cancer Center - University Campus, Worcester,  Massachusetts,  01655,  United States; Recruiting
Pankaj Bhargava  508-856-6884    bhargavp@ummhc.org 

Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States; Recruiting
Lawrence E. Flaherty, MD  313-745-9155    flaherty@karmanos.org 

      CCOP - Beaumont, Royal Oak,  Michigan,  48073-6769,  United States; Recruiting
Jeanne Archer, PhD, APN  248-551-8299    carcher@beaumon.edu 

      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
Kathleen Jo Yost, MD  616-391-1230 

      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
Raymond Sterling Lord, MD  269-373-7488    rlord@wmcc.org 

      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Philip J. Stella, MD  734-712-5237    beekmanl@trinity-health.org 

      Josephine Ford Cancer Center at Henry Ford Health System, Detroit,  Michigan,  48202,  United States; Recruiting
Robert Anthony Chapman, MD  313-916-1332    rchapma1@hfhs.org 

      Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph,  Michigan,  49085,  United States; Recruiting
Cynthia Bender, BA, CRA  269-985-4516    cbender@lakelandregional.org 

      Providence Cancer Institute at Providence Hospital - Southfield, Southfield,  Michigan,  48075,  United States; Recruiting
Anibal Drelichman, MD, MPH, FACP  313-552-0620    adrelichman@yahoo.com 

      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0948,  United States; Recruiting
Laurence H. Baker, DO, FACOI  734-936-3983    bakerl@umich.edu 

      Veterans Affairs Medical Center - Detroit, Detroit,  Michigan,  48201-1932,  United States; Recruiting
Lawrence E. Flaherty, MD  313-576-1000 

      West Michigan Cancer Center, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
Raymond Sterling Lord, MD  616-373-7488    rlord@wmcc.org 

Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
Patrick J. Flynn, MD  952-993-1517    patrick.flynn@usoncology.com 

      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Thomas M. Habermann, MD  507-284-2511 

      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Bruce A. Peterson, MD  612-624-5631 

      Veterans Affairs Medical Center - Minneapolis, Minneapolis,  Minnesota,  55417,  United States; Recruiting
Vicki A. Morrison, MD  612-467-4135    morri002@tc.umn.edu 

Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States; Recruiting
James Tate Thigpen, MD  601-984-5590    jthigpen@medicine.umsmed.edu 

      Veterans Affairs Medical Center - Jackson, Jackson,  Mississippi,  39216,  United States; Recruiting
James Tate Thigpen, MD  601-362-4471 

Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
John Wendall Goodwin, MD  417-269-4520    jwg684@sprg.mercy.net 

      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
William T. Stephenson, MD  816-823-0555 

      CCOP - St. Louis-Cape Girardeau, Saint Louis,  Missouri,  63141,  United States; Recruiting
Bethany G. Sleckman, MD  314-569-6573 

      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting
Michael C. Perry, MD  573-882-4979    perrym@health.missouri.edu 

      Saint Louis University Cancer Center, Saint Louis,  Missouri,  63110,  United States; Recruiting
Paul J. Petruska, MD  314-268-5451    petruspj@slu.edu 

      Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States; Recruiting
Nancy L. Bartlett, MD  314-362-4843 

      Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia,  Missouri,  65201,  United States; Recruiting
William P. Patterson, MD  573-882-6163 

Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States; Recruiting
Patrick W. Cobb, MD  406-259-2245 

Nebraska
      UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha,  Nebraska,  68198-7680,  United States; Recruiting
Margaret Anne Kessinger, MD  402-559-7511    makessin@unmc.edu 

Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States; Recruiting
John Allan Ellerton, MD, CM  702-384-0013    k.vanwagenen@sncrf.org 

      Veterans Affairs Medical Center - Las Vegas, Las Vegas,  Nevada,  89106,  United States; Recruiting
Chitha R. Hulugalle, MD  702-696-3000 

New Hampshire
      New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett,  New Hampshire,  03106,  United States; Recruiting
Douglas Jay Weckstein, MD  603-622-6484    d.weckstein@nhoh.com 

      Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon,  New Hampshire,  03756-0002,  United States; Recruiting
Camilo E. Fadul, MD  603-650-6312    Camilo.e.fadul@dartmouth.edu 

New Jersey
      Cancer Institute of New Jersey at the Cooper University Hospital, Camden,  New Jersey,  08103,  United States; Recruiting
Edison Catalano, MD  856-342-2506 

      Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick,  New Jersey,  08903,  United States; Recruiting
Joseph Aisner, MD  732-235-7401    aisnerjo@umdnj.edu 

New Mexico
      MBCCOP - University of New Mexico HSC, Albuquerque,  New Mexico,  87131,  United States; Recruiting
Cheryl L. Willman, MD  505-272-5837 

      Veterans Affairs Medical Center - Albuquerque, Albuquerque,  New Mexico,  87108-5138,  United States; Recruiting
Cheryl L. Willman, MD  505-265-1711 

New York
      Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx,  New York,  10461,  United States; Recruiting
Joseph A. Sparano, MD  718-904-2555    jsparano@montefiore.org 

      CCOP - North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
Vincent P. Vinciguerra, MD  516-562-8954 

      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse,  New York,  13057,  United States; Recruiting
Jeffrey J. Kirshner, MD  315-472-7504 

      Elmhurst Hospital Center, Elmhurst,  New York,  11373,  United States; Recruiting
Vladimir Benisovich, MD  718-334-3723    beniso@aol.com 

      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting
Daniel P. Petrylak, MD  212-305-1731    dpp5@columbia.edu 

      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States; Recruiting
Richard I. Fisher, MD  585-275-0842    richard_fisher@urmc.rochester.edu 

      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Clifford A. Hudis, MD  212-639-6483 

      Mount Sinai Medical Center, New York,  New York,  10029,  United States; Recruiting
Lewis R. Silverman, MD  212-241-5520    lewis.silverman@mssm.edu 

      New York Weill Cornell Cancer Center at Cornell University, New York,  New York,  10021,  United States; Recruiting
Scott Wadler, MD  212-746-2844    scw2004@med.cornell.edu 

      North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
Daniel R. Budman, MD  516-562-8958 

      NYU Cancer Institute at New York University Medical Center, New York,  New York,  10016,  United States; Recruiting
Amy D. Tiersten, MD  212-652-1916 

      Queens Cancer Center of Queens Hospital, Jamaica,  New York,  11432,  United States; Recruiting
Hans W. Grunwald, MD  718-883-4118    hans.grunwald@mssm.edu 

      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States; Recruiting
Ellis G. Levine, MD  716-845-8547 

      SUNY Upstate Medical University Hospital, Syracuse,  New York,  13210,  United States; Recruiting
Stephen L. Graziano, MD  315-464-8200    grazians@upstate.edu 

      Veterans Affairs Medical Center - Buffalo, Buffalo,  New York,  14215,  United States; Recruiting
Lynn Marie Steinbrenner, MD  716-862-3191    lynn.steinbrenner@med.va.gov 

      Veterans Affairs Medical Center - Syracuse, Syracuse,  New York,  13210,  United States; Recruiting
Stephen L. Graziano, MD  315-476-7461 

North Carolina
      Cape Fear Valley Medical Center, Fayetteville,  North Carolina,  28302-2000,  United States; Recruiting
Kamal M. Bakri, MD  910-609-6910 

      CCOP - Southeast Cancer Control Consortium, Goldsboro,  North Carolina,  27534-9479,  United States; Recruiting
James N. Atkins, MD  336-777-3088 

      Comprehensive Cancer Center at Moore Regional Hospital, Pinehurst,  North Carolina,  28374,  United States; Recruiting
Ellen M. Willard, MD  910-295-9205 

      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States; Recruiting
David Duane Hurd, MD  336-716-2088    dhurd@wfubmc.edu 

      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
Jeffrey Crawford, MD  919-684-5621    crawf006@mc.duke.edu 

      Lenoir Memorial Cancer Center, Kinston,  North Carolina,  28503-1678,  United States; Recruiting
Peter R. Watson, MD  252-559-2200 ext. 201 

      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7295,  United States; Recruiting
Thomas C. Shea, MD  919-966-7746    sheaT@med.unc.edu 

      NorthEast Oncology Associates - Concord, Concord,  North Carolina,  28025,  United States; Recruiting
James Grier Wall, MD  704-783-1370    jwall@northeastmedical.org 

      Veterans Affairs Medical Center - Asheville, Asheville,  North Carolina,  28805-9913,  United States; Recruiting
John C. Lucke, MD  828-299-2540 

      Veterans Affairs Medical Center - Durham, Durham,  North Carolina,  27705,  United States; Recruiting
Michael J. Kelley, MD  919-286-0411 ext. 7326 

      Zimmer Cancer Center at New Hanover Regional Medical Center, Wilmington,  North Carolina,  28402-9025,  United States; Recruiting
Cyrus A. Kotwall, MD  910-763-4630 

Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
Clara D. Bloomfield, MD  614-293-7518    bloomfield-1@medctr.osu.edu 

      CCOP - Columbus, Columbus,  Ohio,  43206,  United States; Recruiting
J. Philip Kuebler, MD, PhD  614-488-2118 

      CCOP - Dayton, Dayton,  Ohio,  45429,  United States; Recruiting
Howard M. Gross, MD  937-832-1093 

      CCOP - Toledo Community Hospital, Toledo,  Ohio,  43623-3456,  United States; Recruiting
Paul L. Schaefer, MD  419-843-6147 

      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0501,  United States; Recruiting
Abdul-Rahman Jazieh, MD, MPH  513-584-3830 

      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195-9001,  United States; Recruiting
George Thomas Budd, MD  216-444-6480 

      Veterans Affairs Medical Center - Cincinnati, Cincinnati,  Ohio,  45220-2288,  United States; Recruiting
Albert F. Muhleman, MD  513-475-6537    albert.muhleman@med.va.gov 

      Veterans Affairs Medical Center - Dayton, Dayton,  Ohio,  45428-1002,  United States; Recruiting
Howard M. Gross, MD  937-268-6511 

Oklahoma
      Oklahoma University Medical Center, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Daniel J. Culkin, MD, FACS  405-271-6900    daniel-culkin@ouhsc.edu 

Oregon
      Cancer Institute at Oregon Health and Science University, Portland,  Oregon,  97201-3098,  United States; Recruiting
Craig R. Nichols, MD  503-494-6346 

      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
Keith S. Lanier, MD  503-216-6260 

      Veterans Affairs Medical Center - Portland, Portland,  Oregon,  97207,  United States; Recruiting
Christopher W. Ryan, MD  503-220-8262 

Pennsylvania
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
Albert M. Bernath, MD  570-271-6466 

      Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States; Recruiting
Witold Boleslaw Rybka, MD, FRCPC  717-531-1050    wrybka@med.hmc.psu.edu 

Rhode Island
      Miriam Hospital at Lifespan, Providence,  Rhode Island,  02906,  United States; Recruiting
William M. Sikov, MD  401-793-7151    wsikov@lifespan.org 

South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States; Recruiting
Jeffrey Kent Giguere, MD  864-241-6251 

      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States; Recruiting
James Dewitt Bearden, MD  864-560-7050 

      Hollings Cancer Center at Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States; Recruiting
Carolyn E. Reed, MD  843-792-9321    reedce@musc.edu 

      Veterans Affairs Medical Center - Charleston, Charleston,  South Carolina,  29401-5799,  United States; Recruiting
Carolyn E. Reed, MD  843-789-7804 

South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States; Recruiting
Loren K. Tschetter, MD  605-328-8044    tidemanb@siouxvalley.org 

Tennessee
      University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis,  Tennessee,  38104,  United States; Recruiting
Mohammad Jahanzeb, MD  901-722-0532 

      Veterans Affairs Medical Center - Memphis, Memphis,  Tennessee,  38104,  United States; Recruiting
Harvey B. Niell, MD  901-523-8990 ext. 5533 

Texas
      Brooke Army Medical Center, Fort Sam Houston,  Texas,  78234-6200,  United States; Recruiting
Mitchell A. Garrison, MD  210-916-3281    mitchell.garrison@cen.amedd.army.mil 

      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
Lucas Wong, MD  254-724-1053    lwong@swmail.sw.org 

      Harrington Cancer Center, Amarillo,  Texas,  79106,  United States; Recruiting
James E. Clarkson, MD  806-359-4673 ext. 228    jclarkson@harringtoncc.org 

      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4095,  United States; Recruiting
Scott Michael Lippman, MD, FACP  713-745-3672 

      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78229-3900,  United States; Recruiting
Geoffrey R. Weiss, MD  210-567-4777    weiss@uthscsa.edu 

      University of Texas Medical Branch, Galveston,  Texas,  77555-0565,  United States; Recruiting
Robert P. Whitehead, MD  409-772-1164    rpwhiteh@utmb.edu 

      Veterans Affairs Medical Center - Amarillo, Amarillo,  Texas,  79106,  United States; Recruiting
Stephen E. Wright, MD  806-359-4673 ext. 230 

      Veterans Affairs Medical Center - Dallas, Dallas,  Texas,  75219,  United States; Recruiting
Jonathan Dowell, MD  214-857-0737 

      Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio,  Texas,  78229,  United States; Recruiting
Geoffrey R. Weiss, MD  210-617-5186 

      Veterans Affairs Medical Center - Temple, Temple,  Texas,  76504,  United States; Recruiting
Phalguni Mukhopadhyay, MD  254-778-4811 ext. 4809 

Utah
      Huntsman Cancer Institute at University of Utah, Salt Lake City,  Utah,  84112-5550,  United States; Recruiting
Wolfram Samlowski, MD  801-585-0255    wolfram.samlowski@hci.utah.edu 

      Veterans Affairs Medical Center - Salt Lake City, Salt Lake City,  Utah,  84148,  United States; Recruiting
Wolfram Samlowski, MD  801-582-1565 ext. 1272 

Vermont
      Green Mountain Oncology Group, Bennington,  Vermont,  05201,  United States; Recruiting
L. Herbert Maurer, MD  802-442-1290    mauh@phin.org 

      Vermont Cancer Center at University of Vermont, Burlington,  Vermont,  05401-3498,  United States; Recruiting
Hyman Bernard Muss, MD  802-847-3827 

Virginia
      Martha Jefferson Hospital, Charlottesville,  Virginia,  22902,  United States; Recruiting
Stefan M. Gorsch, MD  434-982-8410 

      MBCCOP - Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States; Recruiting
John D. Roberts, MD  804-828-0450 

      Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke, Roanoke,  Virginia,  24014,  United States; Recruiting
Paul D. Richards, MD  540-982-0237    paul.richards@usoncology.com 

      Virginia Oncology Associates - Norfolk, Norfolk,  Virginia,  23502,  United States; Recruiting
Paul R. Conkling, MD  757-466-8683 

Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States; Recruiting
Lauren Kenneth Colman, MD  253-403-5259    lauren.colman@multicare.org 

      CCOP - Virginia Mason Research Center, Seattle,  Washington,  98101,  United States; Recruiting
Andrew David Jacobs, MD  206-341-0446 

      Puget Sound Oncology Consortium, Seattle,  Washington,  98109,  United States; Recruiting
Saul E. Rivkin, MD  206-386-2441 

      Veterans Affairs Medical Center - Seattle, Seattle,  Washington,  98108,  United States; Recruiting
William H. Schubach, MD  206-764-2265 

West Virginia
      St. Mary's Medical Center, Huntington,  West Virginia,  25701,  United States; Recruiting
Gerrit A. Kimmey, MD  304-528-4645 

Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting
Tarit Kumar Banerjee, MD, FACP  715-387-5511 

      Ministry Medical Group at Saint Mary's Hospital, Rhinelander,  Wisconsin,  54501,  United States; Recruiting
Dhimant R. Patel, MD  715-361-4714    dpatel@shsmh.org 

      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-0001,  United States; Recruiting
James A. Stewart, MD  608-265-8131    stewart@biostat.wisc.edu 

Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada; Recruiting
A. Robert Turner, MD  780-432-8514    roberttu@cancerboard.ab.ca 

      Tom Baker Cancer Centre - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada; Recruiting
Douglas A. Stewart, MD  403-944-1707 

Canada, Manitoba
      CancerCare Manitoba, Winnipeg,  Manitoba,  R3E 0V9,  Canada; Recruiting
Morel Rubinger, MD, FRCPC  204-787-2113    Morel.rubinger@cancercare.mb.ca 

Canada, New Brunswick
      Moncton Hospital, Moncton,  New Brunswick,  E1C 6ZB,  Canada; Recruiting
Sheldon H. Rubin, MD  506-857-2881    shrubin@sehcc.health.nb.ca 

Canada, Newfoundland and Labrador
      Newfoundland Cancer Treatment and Research Foundation, St. Johns,  Newfoundland and Labrador,  A1B 3V6,  Canada; Recruiting
Kirsty A. Tompkins  709-777-8062 

Canada, Nova Scotia
     

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065658; SWOG-S9704; CAN-NCIC-LY11; CALGB-59903; ECOG-S9704; NCT00004031
Record last reviewed:  December 2004
Last Updated:  March 28, 2005
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004031
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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